Intercept does not expect restrictive boxed warning for Ocaliva

From Reuters - September 25, 2017

(Reuters) - Intercept Pharmaceuticals Inc said its liver drug, Ocaliva, could carry a boxed warning to help ensure proper dosing but does not expect the updated labeling to be restrictive, sending its shares higher.

The stock, which had dropped 41 percent over the past two trading days, rose as much as 6.2 percent on Monday. Shares were up 1.5 percent at $62.40 in late morning trade.

Chief Executive Mark Pruzanski said the company was not anticipating on changes that restrict the use (of the drug) in any part of the population as of today, based on the discussions with the U.S. Food and Drug Administration.

A boxed warning on the label is FDAs strictest warning and calls attention to serious or life-threatening risks of a drug.


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